Type 2 DiabetesNCT00818077
Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food
An observational study of Type 2 Diabetes and Currently Taking Metformin, run by HealthPartners Institute at 1 site in United States.
Trial summary
This study will look at the impact that meals have on blood glucose (sugar) levels. Subjects will be asked to use a Continuous Glucose Monitoring System (CGM), which monitors glucose levels continuously. Breakfast and lunch meals will be provided and must be consumed at the International Diabetes Center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Currently Taking Metformin
- What is being tested?
- Continuous Glucose Monitoring of Carbohydrate Intake
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: type 2 diabetes, 18 years of age of older, currently taking metformin
Who may be able to join
- Female or male
- Age 18 and older
- Diagnosed with type 2 diabetes for a minimum of 6 months
- Is taking metformin for diabetes management; no other diabetes medications
- Has been on a stable dose of metformin for at least 3 months
- HbA1c is 7% or greater and less than 9%; >7% or <9%
Show all 12Show fewer
- BMI <30kg/m2
- Willing to give informed consent
- No evidence of acute illness, fever, undue stress
- Motivated and capable of following the protocol and instructions provided by the healthcare professional
- Available for the study on the scheduled visit days
- Access to telephone communications
Who cannot join
- Under 18 years of age
- Has not been diagnosed with type 2 diabetes for a minimum of 6 months
- Is currently taking other diabetes medications in addition to metformin
- Has taken other diabetes medications within the past 3 months
- HbA1c <7% or >9%
- BMI > 30kg/m2
Show all 14Show fewer
- Unable to follow the study protocol
- No access to telephone communications
- Unable to read and write in English
- Unable to maintain their health, or have undue stress
- Skin abnormalities at the insertion sites that would confound assessment of the effect of the device on the skin
- Allergy to adhesives
- Any concomitant medical condition that would likely affect the evaluation of device performance
- Taken oral or inhaled prednisone or cortisone medications in the previous 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
International Diabetes Center
Minneapolis, Minnesota, 55416
About this study
This study will look at the impact that meals have on blood glucose (sugar) levels. Subjects will be asked to use a Continuous Glucose Monitoring System (CGM), which monitors glucose levels continuously. Breakfast and lunch meals will be provided and must be consumed at the International Diabetes Center.
- Conditions
- Type 2 Diabetes, Currently Taking Metformin
- Being tested
- Continuous Glucose Monitoring of Carbohydrate Intake
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring of Carbohydrate IntakeOther
Also called Navigator CGM System
Subjects eat standard breakfast and lunch and keep food records.
| Study group | Role | What they receive |
|---|---|---|
| Metformin, Type 2 Diabetes | Not described Receives: Other: Continuous Glucose Monitoring of Carbohydrate Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Response to the Fixed Meal
Measured: 4 hour meal test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startJan 2008
- Primary completionJul 2008
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- International Diabetes Center at Park Nicollet, Abbott Diabetes Care
- Responsible party
- Sponsor
- Investigators
- Margaret Powers, PhD, RD, CDE, Principal investigator, International Diabetes Center at Park Nicollet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818077
- Sponsor's protocol ID
- 03654-07-A
- Status last verified
- Aug 2013
- First submitted
- 5 Jan 2009
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
American Diabetes Association. Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007 Jan;30 Suppl 1:S48-65. doi: 10.2337/dc07-S048. No abstract available.
PubMed 17192379Franz MJ, Boucher JL, Green-Pastors J, Powers MA. Evidence-based nutrition practice guidelines for diabetes and scope and standards of practice. J Am Diet Assoc. 2008 Apr;108(4 Suppl 1):S52-8. doi: 10.1016/j.jada.2008.01.021.
PubMed 18358257Crapo PA, Reaven G, Olefsky J. Postprandial plasma-glucose and -insulin responses to different complex carbohydrates. Diabetes. 1977 Dec;26(12):1178-83. doi: 10.2337/diab.26.12.1178.
PubMed 590639
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food
- ClinicalTrials.gov ID
- NCT00818077
- Acronym / sponsor ID
- 03654-07-A
- Conditions
- Type 2 Diabetes, Currently Taking Metformin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- International Diabetes Center at Park Nicollet, Abbott Diabetes Care
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 7 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at the impact that meals have on blood glucose (sugar) levels. Subjects will be asked to use a Continuous Glucose Monitoring System (CGM), which monitors glucose levels continuously. Breakfast and lunch meals will be provided and must be consumed at the International Diabetes Center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin, Type 2 Diabetes | – | Other: Continuous Glucose Monitoring of Carbohydrate Intake |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- type 2 diabetes, 18 years of age of older, currently taking metformin
Key inclusion criteria (12 listed)
- Female or male
- Age 18 and older
- Diagnosed with type 2 diabetes for a minimum of 6 months
- Is taking metformin for diabetes management; no other diabetes medications
- Has been on a stable dose of metformin for at least 3 months
Key exclusion criteria (14 listed)
- Under 18 years of age
- Has not been diagnosed with type 2 diabetes for a minimum of 6 months
- Is currently taking other diabetes medications in addition to metformin
- Has taken other diabetes medications within the past 3 months
- HbA1c <7% or >9%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose Monitoring of Carbohydrate IntakeAlso: Navigator CGM SystemSubjects eat standard breakfast and lunch and keep food records. | Other | Metformin, Type 2 Diabetes |
Primary outcome
Glycemic Response to the Fixed Meal
Time frame: 4 hour meal test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 17192379American Diabetes Association. Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007 Jan;30 Suppl 1:S48-65. doi: 10.2337/dc07-S048. No abstract available.
- Background: PubMed 18358257Franz MJ, Boucher JL, Green-Pastors J, Powers MA. Evidence-based nutrition practice guidelines for diabetes and scope and standards of practice. J Am Diet Assoc. 2008 Apr;108(4 Suppl 1):S52-8. doi: 10.1016/j.jada.2008.01.021.
- Background: PubMed 590639Crapo PA, Reaven G, Olefsky J. Postprandial plasma-glucose and -insulin responses to different complex carbohydrates. Diabetes. 1977 Dec;26(12):1178-83. doi: 10.2337/diab.26.12.1178.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Powers, PhD, RD, CDE principal investigator
International Diabetes Center at Park Nicollet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Currently Taking Metformin, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Response to the Fixed Meal (time frame: 4 hour meal test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00818077, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.